MalfunctionFMC
3612 LITE GLOVE
Received Sep 23, 2016 · Event occurred Sep 20, 2016
Report 9612030-2016-00457 · MDR key 5975070
Device
Product problems
- Material Integrity Problem
- Torn Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS A NUMBER OF COVIDIEN DEVON LIGHT GLOVE HANDLES ARE SPLITTING WHEN THE STAFF TRIES TO OPEN UP THE TUBE THAT SLIDES ON THE OR LIGHT. MANY OF THE GLOVES ARE SQUASHED BEFORE THEY EVEN GET THEM AND THEY ARE TEARING AS SOON AS THEY TRY AND SEPARATE THEM.